Apparatus and method to position a patient for airway management and endotracheal intubation

ABSTRACT

An apparatus and method for properly positioning a patient to allow rapid and effective endotracheal intubation during an anesthetic induction is disclosed. The apparatus includes a plurality of inflatable sections for supporting the patient&#39;s head and upper back, where the inflatable sections are independently inflatable and deflatable with respect to one another so that the patient&#39;s ear and sternum can be aligned in the same horizontal plane. The apparatus also includes an anchoring means that is attached to at least one of the plurality of inflatable sections for anchoring the apparatus in place. An air system connected to the plurality of inflatable sections and including separate connections to the individual inflatable sections operates to provide air to the apparatus. The apparatus optionally includes an independently inflatable cylinder in the anchoring means that is used in pregnant patients.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/353,434, filed Feb. 14, 2006, now allowed, which claims the benefitof U.S. Patent Application Ser. Nos. 60/653,592 filed Feb. 16, 2005, and60/740,086, filed Nov. 28, 2005.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an inflatable pillow configured tofacilitate the alignment of the oropharyngeal, laryngeal, and trachealaxes of the airway of an individual in the supine position prior toinduction of anesthesia and placement of an endotracheal tube. Thepresent invention also relates to a modification of the inflatablepillow to provide left lateral tilt of the uterus as well asfacilitating endotracheal intubation in pregnant patients undergoing aCesarean section.

2. Background of the Related Art

Obesity is an epidemic in the United States and is a leading cause ofmorbidity and premature mortality. It is estimated that 300,000 deaths ayear are related to obesity and close to $100 billion are spent onobesity-related health care costs. Obesity is a chronic conditionassociated with several comorbid disorders such as hypertension,diabetes, heart disease, and sleep apnea. In the United States, theprevalence has been increasing over the past several decades and inrecent published US data (1999 to 2000), 67% of men and 62% of women areoverweight. Further, 28% of men and 34% of women are considered obesewith 5-7% in the morbidly obese category. The overweight populationrepresents a large segment of the surgical caseload and presentssignificant challenges to the anesthesiologist, particularly duringendotracheal intubation.

One of the most important tasks of an anesthesiologist is the managementof the patient's airway during the administration of anesthesia. Inorder to maximize visualization of the larynx during endotrachealintubation, the anesthesiologist must place the patient's head and upperback in the “sniffing” position to properly align the oropharyngeal,laryngeal, and tracheal axes. The obese patient presents a challenge forproper alignment because of excess tissue in the upper back, neck, andoral pharynx.

Physiological changes occurring during pregnancy further complicateairway management in the pregnant patient. Fluid retention, weight gain,enlarged breasts, incompetent lower esophageal-gastric sphincter andfriable mucosal tissue all add to the difficulty of visualization of thelarynx during endotracheal intubation. Accordingly, failed intubationduring anesthetic induction occurs almost ten times more frequently inpregnant patients than in non-pregnant surgical patients.

Endotracheal intubation is a medical procedure in which an endotrachealtube is inserted through the oral cavity into the trachea to providecontrolled or spontaneous ventilation and to protect the lungs fromgastric acid contamination. This protection is provided by a balloon onthe tip of the tube that is inflated when the tube is in the properlocation above the carina. Prior to the induction of anesthesia, apillow or pad is placed under the patient's head to elevate the headabove the shoulders in the “sniffing” position. This “sniffing” positionhelps align the oropharyngeal, laryngeal, and tracheal axes andfacilitates the placement of the endotracheal tube into the trachea.After anesthetic induction, the anesthesiologist or nurse anesthetistplaces a laryngoscope blade into the mouth, the tongue and jaw areslightly elevated, the trachea and vocal cords are visualized and theendotracheal tube is introduced through the mouth into the trachea. Thelaryngoscope blade is then removed, the tube balloon is inflated, andproper ventilation of the lungs is confirmed. This procedure istypically carried out in the operating room. However, it is alsoperformed in emergency situations outside of the operating room such asthe emergency room, hospital room, or at the scene of accidents.

When the obese patient is supine on the operating table, a standardpillow or pad does not elevate the neck and head adequately above theshoulders to provide the necessary “sniffing” position. As a result, aknown current regimen involves placing several layers of blankets underthe upper back, neck, and head of the patient to create a ramp in orderto elevate an obese patient's upper body so that the pinna of the earand the sternum are in the same horizontal plane. This may require tento fifteen blankets in the morbidly obese patient. Although this methodof support is efficacious, there are several disadvantages. First,health care professionals are put at risk for injuries as a result oflifting the obese patient for pre-induction blanket positioning as wellas lifting the patient to remove the blankets after intubation. Blanketsmust also be removed so that the patient's shoulders and arms are levelwith each other in order to minimize the risk of a brachial plexusstretch injury. In addition, the endotracheal tube may become dislodgedwhile lifting the patient to remove the blankets. Further, the cost oflaundering the large number of blankets used in each case issignificant. Moreover, it is difficult and time-consuming to adjust theblanket placement for proper positioning after the patient is on theoperating room table.

The pregnant patient undergoing a Cesarean section, or other surgicalprocedure, presents two major concerns to the anesthesiologist. Inaddition to the physiological changes that occur during pregnancy thatincrease the risk of a difficult intubation, the enlarged, gravid uteruscan partially obstruct the venous return to the heart by compressing theinferior vena cava if the patient is left in the supine position on theoperating room table. This syndrome can cause a 25-30% decrease incardiac output resulting in maternal hypotension and decreased bloodflow to the fetus. In order to alleviate the decrease in venous return,the right side of the pregnant patient is tilted up 1530 degrees to theleft side of the patient to move the uterus away from the inferior venacava. Presently, this “left lateral tilt” is obtained by either placinga liter saline bag under the right side or manually inflating a bladderbag under the patient's right side. The former method is non-adjustableand does not allow adequate tilt in large patients. The latter method isburdensome and time-consuming during the critical part of pre-inductionpreparation and oxygenation.

Accordingly, there is a need for an improved device that allows forspecific adjustments in the position of a patient's upper back, neck andhead to obtain the best alignment of the oropharyngeal, laryngeal, andtracheal axes in obese and pregnant patients so that endotrachealintubation can be performed quickly with minimal trauma to patients.There also exists a need for a device that prevents injury to healthcare professionals performing endotracheal intubation by eliminating theneed to lift obese patients before and after induction of anesthesia.There is a further need for a device that allows anesthesiologists toquickly and adequately obtain a left lateral tilt in pregnant patientsirrespective of the patient's anatomy.

BRIEF SUMMARY OF THE INVENTION

It is an object of the present invention to provide an improved deviceand method for facilitating endotracheal intubation in obese andpregnant patients by providing a device configured to adjust thepatient's upper body to permit alignment of the patient's ear andsternum in the same horizontal plane, a position that produces the bestalignment of the oropharyngeal, laryngeal, and tracheal axes forefficient intubation of the trachea during the critical period ofanesthetic induction. It is yet another object of the present inventionto provide a method and device that allows a quick and efficient leftlateral tilt of the uterus in pregnant patients undergoing a surgicalprocedure, such as a Cesarean section.

These and other objects of the present invention are accomplished byproviding an apparatus for aligning the oropharyngeal, laryngeal, andtracheal axes in the obese and/or pregnant patient. The apparatusincludes a plurality of inflatable sections configured to adjust thepatient's upper body such that the patient's ear and sternum are alignedin the same horizontal plane. The inflatable sections are independentlyinflatable and deflatable with respect to one another or may be groupedso that groups of inflatable section are independently inflatable anddeflatable with respect to other groups. The apparatus also includes ananchoring means attached to at least one of the plurality of inflatablesections. The anchoring means is positioned under the patient and isdesigned to allow the patient's weight to anchor the apparatus in place.The anchoring means is optionally configured with an inflatable cylinderor pocket on the right side so that it can produce a left lateral tiltof a pregnant patient during a surgical procedure. The apparatus furtherincludes an air system that is selectively connected to one or more ofthe inflatable sections for inflating and deflating the inflatablesections independently of one another. The present invention alsoincludes a method for aligning the patient's oropharyngeal, laryngeal,and tracheal axes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of one embodiment of the apparatus of the presentinvention.

FIG. 2 is an alternative embodiment of the apparatus depicted in FIG. 1.

FIG. 3 is a cross section of an illustration of the apparatus inaccordance with the present invention.

FIG. 4 is a perspective side view of the apparatus in accordance withthe present invention.

FIG. 5 is a top plan view of the apparatus in accordance with thepresent invention, viewed from the perspective of an anesthesiologist atthe head of the operating table, including an independently inflatablecylinder.

FIG. 6 is a cross sectional view of the cylinder of FIG. 5.

FIG. 7 is a cross sectional view of the cylinder of FIG. 6 in accordancewith the present invention illustrating a pregnant patient's torsopositioned thereupon.

FIG. 8 is a schematic of an air system in accordance with the presentinvention.

FIG. 9 is a perspective side view of a push button valve assembly usedto inflate/deflate the apparatus in accordance with the presentinvention.

FIG. 10 is an illustration of an obese patient positioned on theapparatus in accordance with the present invention, illustrating properinflation of the apparatus such that the pinna of the ear and sternum(P-S) are in the same horizontal plane.

DETAILED DESCRIPTION OF THE INVENTION

The apparatus and method of the present invention as described andillustrated in FIGS. 1 through 11 overcome the disadvantages set forthabove. Referring to FIG. 1, the apparatus in accordance with the presentinvention is constructed of high-strength plastic or other types ofpolymers that impart strength to the pillow like structure. Theapparatus 10 (referred to hereinafter as a “pillow”) is preferably about16 to 18 inches wide and preferable about 20 to 24 inches long. Thismeasurement may be varied depending on whether the patient is an adult,male or female, or a pediatric patient. Pillow 10 comprises severalsections 12, 14 and 16 that are independently inflatable/deflatableusing pressurized air delivered through inlets/outlets 20 and 22. In oneembodiment of the present invention three inflatable sections 12, 14 and16 are present. In an alternative embodiment, additional sections may beadded depending on whether pillow 10 will be used with a male, female orpediatric patient. An optional anchoring means 18 may be included toanchor pillow 10 using the patient's body weight thus preventing pillow10 from being dislodged or otherwise moved away from the patient's body.Anchoring means 18 can be configured as an extended tail section,fastenable straps, weighted portion, and other such means known by thoseskilled in the art. Anchoring means 18 may be attached to at least oneof the inflatable sections or may be removably coupled to at least oneof the inflatable sections with means such as a zipper, Velcro and thelike. First and second inflatable sections 12, 14 are grouped togetherand inflated and deflated via common inlet/outlet 20 by air system 50,hereinafter described. Third inflatable section 16 is inflated anddeflated via inlet/outlet 22, which is connected to air system 50. Firstand second sections 12, 14 and third section 16 are independentlyinflatable and deflatable.

As those skilled in the art can appreciate, the number of inflatablesections and how they are grouped together for inflation and deflationpurposes can be as varied as the differences in human anatomy dictate.For example and referring to FIGS. 2 and 3, there are shown additionalembodiments of pillow 10 where additional inflatable sections have beenadded. Referring to FIG. 2, inflatable sections 24 and 26 are separatedfrom inflatable section 28 by a no fill section 30. No fill section 30is used to isolate elevation to the patient's abdominal area rather thanelevating the entire side of the patient. Use of no fill section 30 isadvantageous when using pillow 10 to facilitate intubation of pregnantpatients as discussed in detail below. Inflatable sections 24 and 26 areinflated and deflatable via inlet/outlet 32 that is connected to airsystem 50. Inflatable section 28 is inflated and deflated viainlet/outlet 34 that is connected to air system 50. Inflation anddeflation of sections 24, 26 are independent of the inflation anddeflation of section 28.

Referring now to FIGS. 3 and 4, an exemplary embodiment of pillow 10 inaccordance with the present invention is depicted. Pillow 10 includesfirst and second back support inflatable sections 36 and 38, first andsecond base support inflatable sections 40 and 42, a head tiltadjustment inflatable section 44, and first and second head restinflatable sections 46 and 48, grouped together as noted for purposes ofinflation and deflation. Back support inflatable sections 36 and 38 areadjacent anchoring means 18 and provide immediate support for apatient's upper back. Base support inflatable sections 40 and 42 areplaced at the bottom of pillow 10 in order to provide support for backsupport inflatable sections 36 and 38, head tilt adjustment inflatablesection 44, and head rest inflatable sections 46 and 48. Head restinflatable sections 46 and 48 are placed at the top of pillow 10 suchthat a patient's head may be placed on them. Head tilt adjustmentinflatable section 44 is between head rest inflatable sections 46 and 48and base support inflatable sections 40 and 42 and can be inflatedand/or deflated until proper alignment of the pinna of the patient's earand sternum in the same horizontal plane is obtained thus resulting inproper alignment of the patient's oropharyngeal, laryngeal, andtrachealaxes in preparation for intubation.

Referring now to FIG. 5, an alternative embodiment of pillow 10 inaccordance with the present invention is shown. Pillow 10 includes aplurality of inflatable sections 84, 86, 88 that are positioned underthe patient's head and shoulders. Pillow 10 includes an anchoring means18 optionally divided by stitching into left and right side sections 90,98. Right side section 98 includes an independently inflatable cylinderor pocket 92 therewithin. Each side section 90, 98 of pillow 10 ispreferably about 28 inches along its longitudinal sides 100, 102 andpreferably about 16 inches along its latitudinal sides 104, 106.Referring to FIG. 6, independently inflatable cylinder or pocket 92 isdepicted in cross section supported by operating table 94. In analternative embodiment, an inflatable cylinder 92 may be separate fromanchoring means 18, i.e. not enclosed therewithin, and via a quickconnect/disconnect (not shown) may still be connected to air system 50.Cylinder 92 of this alternate embodiment is placed under anchoring means18 of pillow 10 and is supported by operating table 94 in FIG. 6. Thoseskilled in the art can therefore appreciate that such a separatecylinder could thus be configured in various shapes and sizes dependingon the size of the pregnant patient being treated and could be quicklychanged out to suit the size of the patient. FIG. 7 illustrates thepositioning of a pregnant patient 96 on cylinder 92, where cylinder 92is supported by operating table 94.

Independently inflatable cylinder or pocket 92 positioned withinanchoring means 18 can also be configured of various shapes and sizesdepending on the size of the patient being treated. Regardless of theshape or size, independently inflatable cylinder or pocket 92 isgenerally positioned on right side 98 of pillow 10 as depicted in FIG. 5so that, when inflated, it provides left uterine displacement. In oneembodiment of the present invention, independently inflatable section 92is sized and positioned such that its first longitudinal end 108 isabout 5 inches from first inflatable section 84 and its secondlongitudinal end 110 is approximately 5 inches from latitudinal side104. The specific longitudinal placement of independently inflatablesection 92, however, can vary depending on the size of the patient.

Referring now to FIG. 8, there is shown an exemplary air system 50including a pneumatic valve assembly for inflating and deflating thevarious sections of pillow 10 in accordance with the present invention.Air system 50 can be operated to either inflate or deflate independentlygroupings of inflatable sections of pillow 10 until the best anatomicalposition for endotracheal intubation of the patient is achieved. Thoseskilled in the art can appreciate that the number of sections air system50 is designed to inflate is not limited to the number depicted in FIG.8, which simply illustrates the operation of an exemplary air system.Those skilled in the art will also appreciate that air system 50 may behard plumbed in the operating room and connected directly to thecompressed air line of the hospital or may be designed as a portablesystem with a portable canister of compressed air.

When air system 50 is set for inflation, deflate valve 54 is closed inthe closed position and inflate valve 60 is set to the open position. Inone embodiment of air system 50 in accordance with the presentinvention, hospital compressed air supply 52 is routed through air input72, which is provided with a special medical grade quick disconnectfitting to allow for quick disconnect of the system in the event that apressure regulator 56 malfunctions. The compressed air is then routedthrough pressure regulator 56 to ensure proper inflation pressure and toensure that pillow 10 does not become over inflated. Regulator 56 may bean adjustable type pressure regulator allowing an operator to adjust themaximum allowable air line pressure. Alternatively, pressure regulator56 may be a fixed pressure regulator in which the maximum air linepressure is fixed at a predetermined air pressure. On/off switches 62,64, 66 and 67 are either on or off depending on which grouping ofinflatable pillow sections, or which individual inflatable pillowsections, are being inflated or deflated. For example, when base supportgrouping of inflatable sections 40 and 42 and head rest grouping ofinflatable sections 46 and 48 are to be inflated, on/off switch 62 isplaced in the on position. When head tilt adjustment grouping ofinflatable sections 44 are to be inflated, on/off switch 64 is placed inthe on position. When back support inflatable sections 36 and 38 are tobe inflated, on/off switch 66 is placed in the on position.

Conversely, when air system 50 is set for deflation, inflate valve 60 isset to the closed position and deflate valve 54 is set to the openposition. A vacuum generator 58 is operated to draw air out of theinflatable pillows. Vacuum generator 58 uses compressed air to create avacuum allowing for quicker deflation of the various groupings ofinflatable sections. The grouping of inflatable sections can beselectively deflated by turning on/off switches 62, 64 and 66 to the onposition as previously described for inflation. While those skilled inthe art will recognize that it is advantageous to use vacuum generator58 for active deflation of the inflatable sections, the use of vacuumgenerator 58 is optional as the patient's weight will also causedeflation when valve 60 is closed and valve 54 is open to ambient air.Those skilled in the art will also appreciate that the number of inflateand deflate valves and the configuration of air system 50 can vary fromthat depicted in FIG. 8 and still fall within the spirit of the presentinvention.

There is depicted in FIG. 9, according to one embodiment of the presentinvention, an easy to use hand-held push button valve assembly 68 thatis operably connected to air system 50 but allows for easy hand-heldmanipulation of the inflation and deflation process by theanesthesiologist. Valve assembly 68 includes a momentary push buttonvalve 74 that allows for rapid inflation of all inflatable pillowsections when placed in a first position and rapid deflation of allinflatable pillow sections when placed in a second position. The pushbutton valve assembly 68 also includes three or more momentary pushbutton valves 76, 78 and 80 for independently controlling the inflationand deflation of a particular grouping of inflatable pillow sections. Ina first position, buttons 76, 78 and 80 independently allow air fill ofinflatable sections individually or in any group combination. In asecond position, the inflatable sections are deflated individually or inany group combination. A fourth momentary push button valve (not shown)can optionally be added to control inflation and deflation of cylinderor pocket 92 in anchoring means 18, or a separate cylinder placed underanchoring means 18. Alternatively, separate cylinder 92, whetherpositioned within anchoring means 18 or separated from anchoring means18, can be controlled by a momentary push button valve that controls oneof the groupings of inflatable pillow sections.

Now that each component of the present invention has been discussed, thefollowing discussion describes the use of use of the pillow 10 inoperation. Referring to FIGS. 8 and 10, the upper back of a patient isplaced on back support inflatable sections 36 and 38 such that his/herhead is positioned on head rest inflatable sections 46 and 48 andhis/her mid to lower back is positioned on anchoring means 18 in orderto hold the pillow 10 in place. Preferably, pillow 10 is partiallyinflated on the operating table before placing the patient thereon.Alternatively, it would not be outside the scope of the presentinvention if pillow 10 was completely deflated before placing thepatient on it. After the patient is positioned on pillow 10, backsupport inflatable sections 36 and 38, base support inflatable sections40 and 42 and head rest inflatable sections 46 and 48 are slowlyinflated to properly align the upper body so that the pinna and sternumare in the same horizontal plane. Back support inflatable sections 36and 38, base support inflatable sections 40 and 42 and head restinflatable sections 46 and 48 are inflated by setting deflate valve 54to the closed position and inflate valve 60 to the open position. On/offswitch 62 for base support inflatable sections 40 and 42 and head restinflatable sections 46 and 48 is placed in the on position. On/offswitch 66 for back support inflatable sections 36 and 38 is placed inthe on position. Air is supplied to pillow 10 until the “sniffing”position 82 is achieved.

When necessary, back support inflatable sections 36 and 38, base supportinflatable sections 40 and 42 and head rest inflatable sections 46 and48 are deflated by leaving on/off switches 62 and 66 in the on, settinginflate valve 60 to the closed position, setting deflate valve 54 to theopen position, and activating vacuum generator 58 via an easy to accessmanual switch (not shown) to expel the air. During inflation anddeflation, base support inflatable sections 40 and 42 and head restinflatable sections 46 and 48 are inflated or deflated by placing theon/off switch 62 in the on position. Similarly, back support inflatablesections 36 and 38 are independently inflated or deflated by placingon/off switch 66 in the on position. Air is delivered to inflatablepillow sections via air lines 61, 63, and 65. In this manner, all of theinflatable sections can be inflated or deflated independent of oneanother to achieve the correct anatomical position of supporting thepatient's upper back, shoulders, neck and head to align the pinna of theear and sternum in the same horizontal plane.

In order to place the patient in the “sniffing” position 82, thehealthcare professional adjusts the pressure in head tilt adjustmentsection 44 by either inflating or deflating it. The healthcareprofessional can inflate head tilt adjustment inflatable section 44 bysetting deflate valve 54 to the closed position, setting inflate valve60 to the open position, and placing on/off switch 64 for head tiltadjustment inflatable section 44 in the on position. Head tiltadjustment inflatable section 44 is deflatable by leaving on/off switch64 in the on position, setting inflate valve 60 to the closed position,setting deflate valve 54 to the open position, and activating vacuumgenerator 58 to expel the air.

Pillow 10 of the present invention may also be used with a pregnantpatient to achieve proper left lateral tilt and is best described byreferring to FIGS. 5, 6, and 7. The upper back of a pregnant patient isplaced on inflatable section 84 with the patient's neck and headpositioned on inflatable sections 86, 88, respectively. The patient'smid to lower back are positioned on anchoring means 18 in order to holdpillow 10 in place. Inflatable cylinder 92 is positioned under thepatient's right side as she lies on pillow 10. Inflatable sections ofpillow 10 and/or independently inflatable cylinder or pocket 92 arepreferably partially inflated before placing the patient on pillow 10.Alternatively, pillow 10 and/or independently inflatable cylinder orpocket 92 can be completely deflated before placing the patient on it.However, before a healthcare professional attempts to properly align apatient's oropharyngeal, laryngeal, and trachealaxes, inflatablecylinder or pocket 92 must be inflated such that the patient is in theleft lateral tilt position as best seen in FIG. 7. Referring again toFIG. 8, independently inflatable cylinder 92 is inflated by settingdeflate valve 54 to the closed position and inflate valve 60 to the openposition. On/off switch 67 for independently inflatable cylinder 92 isplaced in the on position. Air is supplied to cylinder 92 via air line69 until the patient is placed in the left lateral tilt position. Theremaining inflatable sections 84, 86, 88 are inflated and deflated inthe manner previously discussed in order to properly align the pregnantpatient's oropharyngeal, laryngeal, and trachealaxes before intubation.

The induction of anesthesia in obese and pregnant patients carriessignificant risk of morbidity and mortality secondary to problems facedby health care professionals in managing the airways of these patients.Pillow 10 of the present invention allows health care professionals torapidly and effectively place patients in the proper position to easeplacement of endotracheal tubes and minimize risks to patients. Theinvention has been described in connection with the best mode now knownto the applicant inventors. The invention is not to be limited to thedisclosed embodiment. Rather, the invention covers all of variousmodifications and equivalent arrangements included within the spirit andscope of the disclosure.

1. An apparatus for aligning a patient's oropharyngeal, laryngeal, andtracheal axes comprising: a pillow including a plurality of inflatablesections adapted for supporting the patient's upper back, shoulders,neck and head, each of said inflatable sections being independentlyinflatable and deflatable with respect to each other; wherein when saidplurality of inflatable sections are properly inflated said plurality ofinflatable sections assist in aligning a pinna of an ear and a sternumof the patient in the same horizontal plane. 2.-48. (canceled)